Today, FDA Commissioner Scott Gottlieb, MD, revealed the organization’s plan to curb youth use of electronic nicotine delivery systems, which includes a large-scale undercover crackdown on the sale of these products in stores and online and requesting documents on marketing and research conducted by manufacturers to better understand child and adolescent use.
According to the statement made by Gottlieb, these actions will be included in the new Youth Tobacco Prevention Plan, which will have a specific focus on electronic nicotine delivery systems, or ENDS, like JUUL, a product whose unique features have drawn interest among adolescents.
“The troubling reality is that ENDS, such as e-cigarettes, have become wildly popular with kids,” Gottlieb said. “We understand, by all accounts, many of them may be using products that closely resemble a USB flash drive, have high levels of nicotine and emissions that are hard to see. These characteristics may facilitate youth use by making the products more attractive to children and teens.”
“In some cases, our kids are trying these products and liking them without even knowing they contain nicotine, and that is a problem,” he added. “As we know, the nicotine in these products can rewire an adolescent’s brain, leading to years of addiction. For this reason, the FDA must — and will — move quickly to reverse these disturbing trends and, in particular, address the surging youth uptake of JUUL and other products.”
Gottlieb notes that part of the Youth Tobacco Prevention Plan has already been implemented, with undercover nationwide blitzes beginning on April 6. These will continue until the end of the month and will target retailers in both physical and online shops that sell JUUL products to minors. This blitz, according to Gottlieb, “should serve as notice that we will not tolerate the sale of any tobacco products to youth.”
The FDA has released some information regarding the sale of tobacco products through 40 warning letters published on their website today. Some of these letters are a direct result of the compliance checks.
These letters mark a small but significant moment in the FDA’s crackdown on e-cigarette and tobacco sales to youth. In the statement, Gottlieb notes that 908,280 inspections have been conducted, 70,350 warning letters were written and 17,000 civil money penalty cases were initiated by the organization. Furthermore, the FDA has issued at least 110 No-Tobacco-Sale Order Complaints. These complaints may ban retailers from selling tobacco products for a specified length of time.
One online retailer affected by this initiative is eBay. The website has been made aware of the FDA’s concern about JUUL sales and marketing targeted toward children and teens and according to the statement, has been compliant and swift in its efforts to prevent new listings. Additional communication will be made to manufacturers directly.
In the statement, Gottlieb notes that JUUL Labs will be responsible for responding to requests for documents and specific information on several matters, which include documents related to marketing of the product; research conducted on the effects of JUUL delivery systems pertaining to health, toxicology, behavior and psychology, and youth initiation and use; the demographic appeal of product design features, ingredients or specifications; and adverse events related to use of the product by youth and consumer complaints.
“Make no mistake,” Gottlieb said. “We see the possibility for ENDS products like e-cigarettes and other novel forms of nicotine delivery to provide a potentially less harmful alternative for currently addicted individual adult smokers who still want to get access to satisfying levels of nicotine without many of the harmful effects that come with the combustion of tobacco. But we have got to step in to protect our kids.”
The FDA will continue to disseminate letters to more manufacturers that have similar appeal to children and adolescents. If these manufacturers, including JUUL, do not comply with the organization’s requests, law enforcement measures may be taken. Further enforcement actions are also planned for companies that market these products in a way that may target children or mislead them. More details will be released by the FDA later.
The Youth Tobacco Prevention Plan will also include efforts to make tobacco products safer to users, less appealing and addictive as they relate to youth use. Gottlieb notes that standards and other regulations for ENDS will continue to be pursued by the FDA.
“The youth-focused steps we are taking are consistent with our responsibility to protect kids and significantly reduce tobacco-related disease and death,” Gottlieb said. “I intend to do everything within my power to fulfill that duty.” – by Katherine Bortz